Introduction
As technology enables more rapid advancement in the laboratory sciences and as headlines tout the latest research, understanding how a test gets to market may help you to put such news into its appropriate context.
It is necessary, first, to understand that there are essentially two kinds of tests: those that are manufactured and sold in volume as kits to laboratories and those that are developed within a particular laboratory (called
laboratory-developed assays). In each case, their development and entry into the market – that is, their use on patient specimens – is governed by sets of rules that ensure their accuracy and reliability.
The clinical laboratory tests that are performed using commercially manufactured kits and equipment (primarily tests done on body fluid samples like blood and urine) are subject to the regulations imposed by the U.S. Food and Drug Administration (FDA). In addition, other federal and state health agencies ensure that these laboratory tests meet stringent standards both during the manufacturing process and when they are used in the clinical laboratory.
This article is intended to guide you through the process required for a laboratory test to proceed from conception to market. Research testing, clinical evaluation, development of manufacturing processes and marketing strategies, reimbursement analyses, and review by regulatory authorities in the FDA and the Centers for Medicare and Medicaid Services (CMS) that must take place before a test is approved for market may take years. It is a time-intensive process with no assurance that the product, once marketed, will actually be adopted by health care providers.
(Note: While there are other types of diagnostic tests, including laboratory-developed assays, the rules that govern their development and clinical use are varied and beyond the scope of this article.)
